Eli Lilly and Company
Sr. Director, ADC Drug-Linker Synthetic Process Development
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
**Overview:**At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The current opportunity is within the Bioproduct Research and Development (BR&D) organization, which is a multidisciplinary organization focused on the development and commercialization of biologic therapeutics such as monoclonal antibodies and bioconjugates.
Due to a strategic commitment to the growth of novel modalities such as Antibody-Drug Conjugates (ADCs) and an exciting pipeline of investigational medicines within the Lilly portfolio, we are seeking outstanding candidates to work at this exciting small molecule – biologics interface, focusing on small-molecule drug-linker synthetic chemistry. The successful candidate will interface closely with the biologics development in BR&D and with the Synthetic Molecule Design and Development organization (SMDD) at Lilly.**Position Responsibilities:**To meet the needs of Lilly’s expanding and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate (ADC) team. This role will focus on the design, optimization, and scaling of payload linker chemistry critical to the manufacturing of next-generation ADC therapeutics. The successful candidate will also exhibit a strong commitment in employee development and thrive in a collaborative and fast-paced work environment. * Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs, ensuring alignment with overall program goals.* Collaborate closely with Discovery teams to ensure manufacturability and facilitate smooth transition from early research to CMC development.* Develop scalable, robust, and reproducible processes for payload linker synthesis, enabling seamless technology transfer from development labs to GMP manufacturing.* Build and strengthen internal capabilities by developing team expertise, infrastructure, and technologies related to payload linker process development.* Stay current of emerging technologies and scientific advancements in ADC linker and payload chemistry to maintain competitive edge.* Champion a strong safety culture in all laboratory activities, ensuring proper handling, containment, and risk assessment practices for highly potent compounds.* Provide technical guidance and career development support to team members, including goal setting, performance evaluations, and skills enhancement.* Manage external collaborations with vendors and CDMOs specializing in linker and payload synthesis and process development.* Ensure compliance with regulatory guidelines and support filing activities for INDs, BLAs, and other regulatory submissions.**Basic Requirements:** * Experience in preparing and contributing to regulatory filings, including IND, IMPD, and BLA submissions, with responsibility for drafting and reviewing CMC-related documentation.Ph.D. in synthetic organic chemistry or relevant scientific discipline with > 8 years of experience; B.S. or M.S. with 15+ years of demonstrated equivalent experience in a related field of expertise. Proven leadership experience managing small molecule CMC development programs and leading scientific teams through all stages of development from discovery handoff to GMP manufacturing and regulatory submission.Extensive expertise and scientific knowledge in linker design, payload chemistry, and related bioconjugation strategies.Proven ability to drive innovation in ADC or small molecule process development, with a focus on implementing novel technologies, improving efficiency, and solving complex scientific challenges. **Additional Skills/Preferences:** * Experience working in high-potency laboratory environments, including the development of containment strategies and implementation of occupational safety practices, is highly desirable.* Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus.* Strong leadership skills with a track record of building, mentoring, and retaining high-performing technical teams.* Excellent cross-functional collaboration and communication skills; able to influence without authority and align internal and external stakeholders.**Physical Demands/Travel:**The physical demands of this job are consistent with a lab and office environment**.***The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.***Work Environment:**This position’s work environment is in a laboratory and office environment.
*The* *work* *environment* *characteristics* *described* *here* *are* *representative of those an employee encounters while performing the essential functions of this job.**\*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.*At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr
Due to a strategic commitment to the growth of novel modalities such as Antibody-Drug Conjugates (ADCs) and an exciting pipeline of investigational medicines within the Lilly portfolio, we are seeking outstanding candidates to work at this exciting small molecule – biologics interface, focusing on small-molecule drug-linker synthetic chemistry. The successful candidate will interface closely with the biologics development in BR&D and with the Synthetic Molecule Design and Development organization (SMDD) at Lilly.**Position Responsibilities:**To meet the needs of Lilly’s expanding and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate (ADC) team. This role will focus on the design, optimization, and scaling of payload linker chemistry critical to the manufacturing of next-generation ADC therapeutics. The successful candidate will also exhibit a strong commitment in employee development and thrive in a collaborative and fast-paced work environment. * Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs, ensuring alignment with overall program goals.* Collaborate closely with Discovery teams to ensure manufacturability and facilitate smooth transition from early research to CMC development.* Develop scalable, robust, and reproducible processes for payload linker synthesis, enabling seamless technology transfer from development labs to GMP manufacturing.* Build and strengthen internal capabilities by developing team expertise, infrastructure, and technologies related to payload linker process development.* Stay current of emerging technologies and scientific advancements in ADC linker and payload chemistry to maintain competitive edge.* Champion a strong safety culture in all laboratory activities, ensuring proper handling, containment, and risk assessment practices for highly potent compounds.* Provide technical guidance and career development support to team members, including goal setting, performance evaluations, and skills enhancement.* Manage external collaborations with vendors and CDMOs specializing in linker and payload synthesis and process development.* Ensure compliance with regulatory guidelines and support filing activities for INDs, BLAs, and other regulatory submissions.**Basic Requirements:** * Experience in preparing and contributing to regulatory filings, including IND, IMPD, and BLA submissions, with responsibility for drafting and reviewing CMC-related documentation.Ph.D. in synthetic organic chemistry or relevant scientific discipline with > 8 years of experience; B.S. or M.S. with 15+ years of demonstrated equivalent experience in a related field of expertise. Proven leadership experience managing small molecule CMC development programs and leading scientific teams through all stages of development from discovery handoff to GMP manufacturing and regulatory submission.Extensive expertise and scientific knowledge in linker design, payload chemistry, and related bioconjugation strategies.Proven ability to drive innovation in ADC or small molecule process development, with a focus on implementing novel technologies, improving efficiency, and solving complex scientific challenges. **Additional Skills/Preferences:** * Experience working in high-potency laboratory environments, including the development of containment strategies and implementation of occupational safety practices, is highly desirable.* Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus.* Strong leadership skills with a track record of building, mentoring, and retaining high-performing technical teams.* Excellent cross-functional collaboration and communication skills; able to influence without authority and align internal and external stakeholders.**Physical Demands/Travel:**The physical demands of this job are consistent with a lab and office environment**.***The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.***Work Environment:**This position’s work environment is in a laboratory and office environment.
*The* *work* *environment* *characteristics* *described* *here* *are* *representative of those an employee encounters while performing the essential functions of this job.**\*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.*At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr